UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012261
Receipt number R000014339
Scientific Title The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.
Date of disclosure of the study information 2014/01/01
Last modified on 2014/06/11 15:41:45

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Basic information

Public title

The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.

Acronym

The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.

Scientific Title

The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.

Scientific Title:Acronym

The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.

Region

Japan


Condition

Condition

Patients that undergoing surgery for lung tumor requring one lung ventilation.

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To measure changes in blood oxygen partial pressure for changing of administration oxygen concentration of CPAP during the one lung ventilation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood oxygen partial pressure

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Continuous positive airway pressure of oxygen concentration 100%

Interventions/Control_2

Continuous positive airway pressure of oxygen concentration 50%

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with lung tumor

Key exclusion criteria

History of ischemic heart disease.
History of ischemic brain disease.
NYHA (New York Heart Association) classification is greater than 2.
Hugh-Jones classification is greater than 2.
SPO2 is less than 95%.
PaO2 is less than 70mmHg.
BMIis greater than 29 kg/m2.
ASA-PS classificationis greater than 2.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name kazuhiro kito

Organization

Gifu University Hospital

Division name

Department of Anesthesiology and pain medicine

Zip code


Address

1-1 yanagido gifu city

TEL

058-230-6404

Email

kitokazu1979@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name kazuhiro kito

Organization

Gifu University Hospital

Division name

Department of Anesthesiology and pain medicine

Zip code


Address

1-1 yanagido gifu city

TEL

058-230-6404

Homepage URL


Email

kitokazu1979@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology and Pain medicine, Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

NO

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2013 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 11 Day

Last modified on

2014 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014339


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name